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| Name | Class |
|---|---|
| Ministry of Health and Welfare | AMBIG |
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Data Analysis and Physical Function Evaluation Index Development for Early Diagnosis and Monitoring of ICU-acquired weakness
ICU-acquired weakness (ICU-AW) is a prevalent complication, occurring in more than 50% of ICU patients, and has severe long-term effects on patient outcomes. This condition not only prolongs the duration of hospital stay but also persists long after discharge, continuously impacting patients' health and quality of life. Therefore, monitoring, prevention, and rehabilitation of ICU-AW should not be limited to the ICU period but should continue after transfer to general wards and after discharge. This study aims to provide foundational data for developing a platform capable of continuously monitoring and delivering rehabilitation therapy for ICU-AW from ICU admission through the post-discharge period.
Recent meta-analyses have shown that providing rehabilitation for ICU patients improves physical function at discharge, reduces ICU stay by 0.8 days, and shortens total hospital stay by 1.75 days. Additionally, it increases the distance patients can walk unassisted at discharge, the number of patients capable of standing, the duration of ventilator-free days, and the percentage of patients discharged home. Understanding the recovery process of ICU-AW as a continuum from ICU to post-discharge is essential, and the necessity of continuous rehabilitation throughout this process is evident. However, the challenge lies in implementing this in real-world practice.
This study seeks to provide foundational data for developing personalized educational programs applicable to remote digital therapeutics in the future.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort | This exploratory study aims to investigate the relationship between activity levels/muscle mass and clinical indicators. ., assuming an estimated Spearman's rank correlation of 0.7, a sample size of 43 participants would yield a two-sided 95% confidence interval with a margin of error of 0.17. Considering a dropout rate of 15%, a total of 51 participants is required. This study will begin enrolling ICU patients with weakness following approval from the Institutional Review Board (IRB). With an estimated enrollment rate of fewer than one participant per week, the enrollment period is expected to last approximately 12 months. -Lifelog via Wearable Device (Accelerometer::Fitbit) Participants will wear the Fitbit Charge 5 from the time of study registration after ICU admission until two weeks post-ICU discharge. If the participant meets the criteria for sarcopenia based on bioelectrical impedance analysis (BIA), a nerve conduction study will be conducted |
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| Measure | Description | Time Frame |
|---|---|---|
| MRC sum | Total Score 60, 12-group muscles, each score 0-5. The Score below 48 is diagnosed a s ICU aquired weakness. | Within 72 hours of ICU admission |
| Grip strength | To assess forearm strength, grip strength is measured using a dynamometer. Two measurements are taken on both the left and right sides, and the average value is recorded. | Within 72 hours of ICU admission |
| FSS-ICU | Functional status Score for the4 Intensive Care Unit 5 Functional movement : Rolling / Supine to Sit / Sit to Stand / Sitting on the edge of the bed, Walking Each item is scored from 0 to 7 based on the level of assistance needed, with 0 indicating complete inability and 35 indicating independent function. | Within 72 hours of ICU admission |
| JH-highest mobility scale | There are a total of 8 stages : lying in bed(1pt) Limited to activities in bed only(2 pt) Sitting up in bed (3 pt) Sitting on a chair beside the bed(4 pt) Standing(5 pt) Walking 10 steps beside the bed(6pt) Walking more than 7 meters (7pt) Walking more than 76 meters (8 pt) | Within 72 hours of ICU admission |
| Body composition | Height, weight, BMI, body fat percentage, Muscle mass are measured using an InBody device | Within 72 hours of ICU admission |
| US ( muscle thickness) | Muscle Thickness for a total of 6 tems in the upper and lower limbs, swallowing muscles , is measured using ultrasound examination | Within 72 hours of ICU admission |
| Measure | Description | Time Frame |
|---|---|---|
| MRC sum | Total Score 60, 12-group muscles, each score 0-5. The Score below 48 is diagnosed a s ICU aquired weakness. | Within 24 hours of ICU discharge |
| Grip strength | To assess forearm strength, grip strength is measured using a dynamometer. Two measurements are taken on both the left and right sides, and the average value is recorded. |
| Measure | Description | Time Frame |
|---|---|---|
| JH-highest mobility scale(T3) | There are a total of 8 stages : lying in bed(1pt) Limited to activities in bed only(2 pt) Sitting up in bed (3 pt) Sitting on a chair beside the bed(4 pt) Standing(5 pt) Walking 10 steps beside the bed(6pt) Walking more than 7 meters (7pt) Walking more than 76 meters (8 pt) | After 2 weeks of GW admission |
Inclusion Criteria:
Exclusion Criteria:
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Patients admitted to the MICU who are 19 years of age, SamsungMC
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | Seoul | 06351 | South Korea |
Registration number, age, gender, study measurements.
From October 1, 2025, to October 1, 2028.
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| C000657744 | postintensive care syndrome |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Fitbit charge 5 | Activity amount assessment The Fitbit Charge 5 is a wristband device equipped with an accelerometer that detects movement across three axes. It tracks information such as step count, distance traveled, calories burned, and active minutes, recording data from the time of wear until the battery depletes. This wearable device enables lifelogging through accelerometry. The Fitbit Charge 5 will be worn continuously from ICU admission upon study enrollment through to two weeks post-ICU discharge. | During ICU status |
| Nerve conduction study | IF Sarcopenia are met via Body Composition Assessment, nerve conduction study (NCS) is performed. NCS is conducted to evaluate peripheral nerve function and to determine the presence of peripheral neuropathy in this study. The nerve conduction study uses electrical stimulation to measure nerve conduction velocity, latency, and amplitude | Within 72 hours of ICU admission |
| Clinical Characteristics | Age,Diagnosis,CCI,Medical History,Education Level,Marital status | Within 72 hours of ICU admission |
| Within 24 hours of ICU admission |
| FSS-ICU | Functional status Score for the4 Intensive Care Unit 5 Functional movement : Rolling / Supine to Sit / Sit to Stand / Sitting on the edge of the bed, Walking Each item is scored from 0 to 7 based on the level of assistance needed, with 0 indicating complete inability and 35 indicating independent function. | Within 24 hours of ICU discharge |
| JH-highest mobility scale | There are a total of 8 stages : lying in bed(1pt) Limited to activities in bed only(2 pt) Sitting up in bed (3 pt) Sitting on a chair beside the bed(4 pt) Standing(5 pt) Walking 10 steps beside the bed(6pt) Walking more than 7 meters (7pt) Walking more than 76 meters (8 pt) | Within 24 hours of ICU discharge |
| Fitbit charge 5 | Activity amount assessment The Fitbit Charge 5 is a wristband device equipped with an accelerometer that detects movement across three axes. It tracks information such as step count, distance traveled, calories burned, and active minutes, recording data from the time of wear until the battery depletes. This wearable device enables lifelogging through accelerometry. The Fitbit Charge 5 will be worn continuously from ICU admission upon study enrollment through to two weeks post-ICU discharge. | Within 24 hours of ICU discharge |
| US -muscle thickness (T2) | Muscle Thickness for a total of 6 tems in the upper and lower limbs, swallowing muscles , is measured using ultrasound examination | Within 24 hours of ICU discharge |
| Body composition(T2) | Height, weight, BMI, body fat percentage, Muscle mass are measured using an InBody device | Within 24 hours of ICU discharge |
| MRC sum (T3) |
Total Score 60, 12-group muscles, each score 0-5. The Score below 48 is diagnosed a s ICU aquired weakness. |
| After 2 weeks of GW admission |
| Fitbit charge 5 (T3) | Activity amount assessment The Fitbit Charge 5 is a wristband device equipped with an accelerometer that detects movement across three axes. It tracks information such as step count, distance traveled, calories burned, and active minutes, recording data from the time of wear until the battery depletes. This wearable device enables lifelogging through accelerometry. The Fitbit Charge 5 will be worn continuously from ICU admission upon study enrollment through to two weeks post-ICU discharge. | After 2 weeks of GW admission |
| FSS-ICU(T3) | Functional status Score for the4 Intensive Care Unit 5 Functional movement : Rolling / Supine to Sit / Sit to Stand / Sitting on the edge of the bed, Walking Each item is scored from 0 to 7 based on the level of assistance needed, with 0 indicating complete inability and 35 indicating independent function. | After 2 weeks of GW admission |
| Grip strength(T3) | To assess forearm strength, grip strength is measured using a dynamometer. Two measurements are taken on both the left and right sides, and the average value is recorded. | After 2 weeks of GW admission |